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Tevogen Bio Oncology Reports Top-Line Revenue Forecast of $1 Billion in Launch Year and Cumulative 5-Year Estimate Between $10 Billion and $14 Billion; Forecasts for Non-Oncology Therapeutic Areas to Follow

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Tevogen Bio, a clinical-stage specialty immunotherapy biotech (Nasdaq: TVGN), has announced its top-line revenue forecast for its oncology pipeline. The company projects $1 billion in revenue for the launch year and a cumulative 5-year estimate between $10 billion and $14 billion. This forecast is based on Tevogen's unique, faster, and cost-efficient drug development model.

The company's first pivotal study with TVGN 489 is designed to help cancer patients undergoing immunosuppressive treatments and chemotherapy combat SARS-CoV-2 infection. Tevogen's pipeline includes treatments for various cancers, rheumatoid arthritis, psoriatic arthritis, Long COVID, and multiple sclerosis.

Tevogen's approach reflects its business philosophy of achieving commercial success through patient accessibility. The total eligible patient population in the US exceeds 2 million.

Positive
  • Projected $1 billion revenue in launch year
  • Cumulative 5-year revenue estimate between $10-14 billion
  • Large eligible patient population of over 2 million in the US
  • Diverse pipeline addressing multiple therapeutic areas
  • Unique, faster, and cost-efficient drug development model
Negative
  • Revenue projections are forecasts and may not materialize
  • Clinical-stage company with no current marketed products
  • Potential competition in the immunotherapy market

Insights

The revenue forecast for Tevogen Bio's oncology pipeline is extremely ambitious, projecting $1 billion in the launch year and a cumulative 5-year estimate between $10 billion and $14 billion. These figures are substantial for a clinical-stage biotech, especially considering the company's current market cap. The forecast hinges on the success of TVGN 489 for treating SARS-CoV-2 in cancer patients, a niche but potentially important market.

Key points to consider:

  • The addressable market of over 2 million eligible patients in the US is significant.
  • The company's focus on patient accessibility could drive adoption but may impact pricing and margins.
  • The pipeline diversity, including non-oncology areas, suggests potential for additional revenue streams not yet forecasted.
  • As a clinical-stage company, these projections carry high risk and depend on successful trials and regulatory approvals.

Investors should approach these projections cautiously, considering the inherent uncertainties in drug development and market penetration for novel therapies.

Tevogen Bio's focus on SARS-CoV-2 treatment for cancer patients undergoing immunosuppressive treatments addresses a critical unmet need. The persistence of COVID-19 as a threat to immunocompromised individuals makes TVGN 489 a potentially valuable asset. The pipeline's diversity is impressive, targeting various cancers and conditions:

  • TVGN 489 for hematologic and solid tumor patients with COVID-19
  • TVGN 920 for cervical cancer prevention
  • TVGN 930 for EBV-associated lymphomas
  • TVGN 960 for mouth and throat cancer

The company's off-the-shelf, genetically unmodified T cell approach could offer advantages in manufacturing and cost-effectiveness. However, the success of these therapies depends on robust clinical data demonstrating efficacy and safety. The ambitious revenue projections will require rapid market penetration and favorable pricing, which may be challenging in the current healthcare landscape.

  • Total eligible patients in the US exceed 2 million.
  • Treatment of SARS-CoV-2 infection in solid and hematologic cancer patients under active treatment.
  • Reflects business philosophy of commercial success through patient accessibility.

WARREN, N.J., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Tevogen Bio (“Tevogen” or “Tevogen Bio Holdings Inc.”) (Nasdaq: TVGN), a clinical-stage specialty immunotherapy biotech developing off-the-shelf, genetically unmodified T cell therapeutics to treat infectious disease and cancers, today announced its top-line revenue forecast for its oncology pipeline, projecting $1 billion in revenue in its launch year and a cumulative 5-year estimate of between $10 billion and $14 billion. This forecast reflects the company’s unique, faster, and cost-efficient drug development model which has the potential to serve as a blueprint to ensure sustainable medical innovation for years to come.

"At Tevogen, we strive to turn our vision into reality ensuring our commitment translates into tangible results. Our priority is the well-being of cancer patients. With compelling evidence that SARS-CoV-2 remains a serious threat to those undergoing immunosuppressive treatments and chemotherapy, our first pivotal study with TVGN 489 is being designed specifically to help these vulnerable patients combat the infection," commented Sadiq Khan, Chief Commercial Officer.

Pipeline

  • TVGN 489:
    • Treatment of SARS-CoV-2 infection in patients with B cell hematologic cancer [part of Tevogen Bio Oncology forecast]
    • Treatment of SARS-CoV-2 infection in patients with other cancers [part of Tevogen Bio Oncology forecast]
    • SARS-CoV-2 infection in patients under treatment for rheumatoid arthritis
    • SARS-CoV-2 infection in patients under treatment for and psoriatic arthritis
    • Treatment of Long COVID
  • TVGN 920: Cervical cancer prevention
  • TVGN 930: EBV-associated lymphomas
  • TVGN 960: Mouth and throat cancer
  • TVGN 601: Multiple sclerosis

Forward Looking Statements

This press release contains certain forward-looking statements, including without limitation statements relating to: expectations regarding the healthcare and biopharmaceutical industries; Tevogen’s development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases, cancer and neurological disorders, including TVGN 489 for the treatment of COVID-19 and Long COVID; Tevogen’s ability to develop additional product candidates, including through use of Tevogen’s ExacTcell platform; the anticipated benefits of ExacTcell; expectations regarding Tevogen’s future clinical trials; and Tevogen’s ability to generate revenue in the future. Forward-looking statements can sometimes be identified by words such as “may,” “could,” “would,” “expect,” “anticipate,” “possible,” “potential,” “goal,” “opportunity,” “project,” “believe,” “future,” and similar words and expressions or their opposites. These statements are based on management’s expectations, assumptions, estimates, projections and beliefs as of the date of this press release and are subject to a number of factors that involve known and unknown risks, delays, uncertainties and other factors not under the company’s control that may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements.

Factors that could cause actual results, performance, or achievements to differ from those expressed or implied by forward-looking statements include, but are not limited to: that Tevogen will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; the effect of the recent business combination with Semper Paratus Acquisition Corporation (the “Business Combination”) on Tevogen’s business relationships, operating results, and business generally; the outcome of any legal proceedings that may be instituted against Tevogen; changes in the markets in which Tevogen competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; changes in domestic and global general economic conditions; the risk that Tevogen may not be able to execute its growth strategies or may experience difficulties in managing its growth and expanding operations; the risk that Tevogen may not be able to develop and maintain effective internal controls; costs related to the Business Combination and the failure to realize anticipated benefits of the Business Combination; the failure to achieve Tevogen’s commercialization and development plans and identify and realize additional opportunities, which may be affected by, among other things, competition, the ability of Tevogen to grow and manage growth economically and hire and retain key employees; the risk that Tevogen may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; the ability to develop, license or acquire new therapeutics; that Tevogen will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; the risk of regulatory lawsuits or proceedings relating to Tevogen’s business; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, approval and commercial development; risks associated with intellectual property protection; Tevogen’s limited operating history; and those factors discussed or incorporated by reference in Tevogen’s Annual Report on Form 10-K and subsequent filings with the SEC.

You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Tevogen undertakes no obligation to update any forward-looking statements, except as required by applicable law.


FAQ

What is Tevogen Bio's projected revenue for its oncology pipeline in the launch year?

Tevogen Bio (TVGNW) projects $1 billion in revenue for its oncology pipeline in the launch year.

What is Tevogen Bio's cumulative 5-year revenue estimate for its oncology pipeline?

Tevogen Bio (TVGNW) estimates a cumulative 5-year revenue between $10 billion and $14 billion for its oncology pipeline.

What is the primary focus of Tevogen Bio's first pivotal study with TVGN 489?

Tevogen Bio's first pivotal study with TVGN 489 focuses on treating SARS-CoV-2 infection in cancer patients undergoing immunosuppressive treatments and chemotherapy.

How many eligible patients are there in the US for Tevogen Bio's treatments?

According to the press release, the total eligible patient population in the US for Tevogen Bio's treatments exceeds 2 million.

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Biotechnology
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